← Back to Search

Other

SPY001-001 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Spyre Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy men and women of non-childbearing potential
Be older than 18 years old
Must not have
Donation or loss of >1 unit of whole blood within 1 month prior to dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 40 weeks
Awards & highlights

Summary

"This trial is testing a new drug called SPY001-001 in healthy people to see if it is safe to use and how the body processes it. It will involve giving different doses of the drug

Who is the study for?
This trial is for healthy individuals who want to participate in a study testing the safety and effects of a new medication, SPY001-001. Specific eligibility details are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.
What is being tested?
The study is evaluating SPY001-001, which is being compared to a placebo (a substance with no active drug). It's designed to assess how safe the drug is, how well it's tolerated by the body, and what happens to it inside the body over time after single or multiple doses.
What are the potential side effects?
Since this is a first-in-human study for SPY001-001, potential side effects are unknown. However, common side effects in such trials can include headache, nausea, fatigue or reactions at the injection site. Placebo groups generally experience fewer or no side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy and cannot become pregnant or get someone pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not donated or lost more than one unit of blood in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment emergent adverse events
Secondary outcome measures
ADA
AUC
Cmax
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1-6 Experimental ArmExperimental Treatment1 Intervention
Participants will receive a single dose of SPY001-001 in a dose escalation format
Group II: MAD Cohorts 1-3 Experimental ArmExperimental Treatment1 Intervention
Participants will receive two doses of SPY001-001 in a dose escalation format
Group III: SAD Cohorts 1-6 Placebo ArmPlacebo Group1 Intervention
Participants will receive a single dose of placebo
Group IV: MAD Cohorts 1-3 Placebo ArmPlacebo Group1 Intervention
Participants will receive two doses of placebo

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Spyre Therapeutics, Inc.Lead Sponsor
Altasciences Company Inc.Industry Sponsor
12 Previous Clinical Trials
447 Total Patients Enrolled
Deanna Nguyen, MDStudy ChairSpyre Therapeutics
1 Previous Clinical Trials
233 Total Patients Enrolled
~48 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top